Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Monovalent Avian Influenza VLP (H7N9), Monovalent Avian Influenza VLP (H5N1)
Monovalent Avian Influenza VLP · 4 trials · 2 indications
Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Geometric mean titer (GMT) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Placebo |
| Group B | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21 |
| Group C | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group D | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group E | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group F | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group G | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group H | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Name | Type | Description |
|---|---|---|
| Monovalent Avian Influenza VLP (H7N9) | BIOLOGICAL | - |
| Matrix-M1™ adjuvant | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| Adjuvant 1 | BIOLOGICAL | - |
| Monovalent Avian Influenza VLP (H5N1) | BIOLOGICAL | Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21 |
| Monovalent Avian Influenza VLP (H5N1); Adjuvant | BIOLOGICAL | Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21 |
| Saline Placebo | BIOLOGICAL | Placebo; intramuscular, deltoid, Day 0 and Day 21 |
Inclusion Criteria: 1. Healthy adult male or female, 18 to 64 years of age, 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of child-bearing potential must have a negative urine pregnancy test prior to each vaccination,...
Monovalent Avian Influenza VLP is an investigational vaccine candidate developed for protection against avian influenza, including pandemic influenza strains. It is being studied for use against H7N9 and H5N1 avian influenza viruses, which are considered potential pandemic threats. The candidate is designed for use in healthy adult volunteers as part of pandemic preparedness efforts.
Monovalent Avian Influenza VLP is being developed by Novavax, Inc., which trades on the Nasdaq under the ticker NVAX. Novavax is a vaccine development company focused on infectious disease prevention. The company has conducted multiple Phase 1 clinical trials of this candidate in the United States and Australia.
Monovalent Avian Influenza VLP is in Phase 1 clinical development. All three completed trials were Phase 1 dose-ranging studies. The candidate is investigational and has not been approved by the FDA. No active trials are currently listed for this candidate, and all completed studies have been closed.
Monovalent Avian Influenza VLP has been evaluated in three completed Phase 1 trials: NCT02078674, a 610-participant H7N9 dose-ranging study in the United States; NCT01897701, a 280-participant H7N9 study in Australia; and NCT01596725, a 333-participant H5N1 study in the United States. A fourth listed study, NCT01594320, also enrolled 333 participants.
Yes, Monovalent Avian Influenza VLP is also known as Monovalent Avian Influenza VLP (H7N9) and Monovalent Avian Influenza VLP (H5N1). These names refer to the same vaccine candidate developed by Novavax. The parenthetical strain designations distinguish the H7N9 and H5N1 formulations studied in separate Phase 1 trials.